Tandem Diabetes Care, Inc., a medical device company,has expanded its voluntary recall of specific lots of insulin cartridges that are used with the t:slim insulin pump. The affected cartridges may be at risk for leaking. This could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event.

“The safety of our customers is our top priority. For that reason, even after our previous announcement Tandem’s team continued to perform further testing. Based on this work we recognized that additional cartridge lots could also be at risk for leaking and so we are expanding the scope of this recall,” said Kim Blickenstaff, president and CEO of Tandem. “We are confident that we have identified all of the affected cartridge lots that may have been shipped to customers or distributors and that we have implemented appropriate corrective actions to prevent this from happening in the future.”

Customers should discontinue using cartridges labeled with any of the lot numbers listed below. The affected lots shipped to customers or distributors represent an aggregate of approximately 13,000 boxes of cartridges (10 cartridges per box). The affected lots announced on January 10, 2014 were shipped from December 17, 2013 to January 10, 2014. The affected lots announced on January 20, 2014 were shipped prior to October 16, 2013.

Affected Lot Numbers announced on January 20, 2014 includes: M000857, M001414 , M001454, M000869, M001415 , M001455 , M001344 , M001416 , M001456 , M001345 , M001417 , M001457 , M001346 , M001420 , M001458 , M001347 , M001421 , M001459 , M001389 , M001422 , M001460 , M001390 , M001423 , M001528 , M001391 , M001451 , M001529 , M001392 , M001452 , M001530 , M001393 , M001453 , M001532 and on January 10, 2014 includes: M001963 , M002028 , M001964 , M002029 , M001973 , M002030 , M001974 , M002082 , M001979 , M002083 , M001980 , M002096 , M001987 , M002097 , M001988 , M002099 , M001990 , M002100 , M001991 , M002119 , M002027 , M002120.

All other cartridge lots shipped to customers or distributors and the t:slim Insulin Pump are not affected by this recall. The Company, or its authorized distributors, is asking customers who received affected cartridges to call Tandem Technical Support to receive replacement cartridges at no charge. Tandem expects to have sufficient quantities of cartridges to replace affected lots in a timely manner. Tandem Customer Support is available 24 hours a day, seven days a week at 1-877-801-6901.

The Company has determined that under certain conditions a specific piece of equipment used in the cartridge test process caused the affected cartridges to be at risk for leaking. Tandem has already implemented modifications to the cartridge manufacturing test process to prevent this issue from occurring in the future, and the Company’s manufacturing facility is able to support ongoing customer demand.

The Company is also working with its customers and distributors to replace cartridges subject to the recall. Based on the periods during which the affected lots were shipped, the Company believes a significant number of the affected cartridges have already been used and therefore will not be exchanged. In addition to the expenses associated with replacing affected cartridges, the Company may also incur additional logistical shipping fees and other recall coordination costs. Tandem is also in the process of evaluating additional cartridges still in the Company’s internal inventory to determine whether they will be usable, and may incur expenses with those that are unusable.

Tandem Diabetes Care, Inc. is a medical device company with an innovative, user-centric and integrated approach to the design, development and commercialization of products for people with insulin-dependent diabetes.